Services

Early Regulatory Development

  • Interaction to develop regulatory plan. This can include sIRB assistance prior to grant submission, FDA IND/IDE consultation or submission, feasibility visits with sponsors, assistance with protocol and Data Safety Monitoring Board creation, and clinicaltrials.gov consultation or submission. 

Regulatory Submissions and Maintenance

  • We can prepare, submit, and maintain HawkIRB, commercial IRB, and sIRB submissions. We can also assist investigators, coordinators, and study staff in their submissions. 

Education and Training

  • We can provide individual or group regulatory education and training to researchers and study staff or study groups. 

FDA Inspections

  • The ICTS Regulatory Core can be a resource to researches and study staff when preparing for an FDA inspection or preparing and implementing responses to the FDA inspection. 

Request Services 

To request services please fill out the link below 

 

Help the Institute for Clinical and Translational Science at the University of Iowa continue making new strides in medical research by citing the NIH CTSA program grant UM1TR004403.

For Investigators